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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceANGIO-SEAL VASCULAR CLOSURE DEVICE:SELF-TIGHTENING SLIPKNOT(STS)
Generic NameDevice, hemostasis, vascular
ApplicantTerumo Medical Corporation
950 Elkton Blvd.
Elkton, MD 21921
PMA NumberP930038
Supplement NumberS029
Date Received01/08/2001
Decision Date07/26/2001
Product Code MGB 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE SELF-TIGHTENING SLIPKNOT (STS) MODIFICATION TO THE ANGIO-SEAL VASCULAR CLOSURE DEVICE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ANGIO-SEAL VASCULAR CLOSURE DEVICE: SELF-TIGHTENING SLIPKNOT (STS) AND IS INDICATED FOR CLOSING AND REDUCING THE TIME TO HEMOSTASIS AT THE FEMORAL ARTERIAL PUNCTURE SITE IN PATIENTS WHO HAVE UNDERTONE A DIAGNOSTIC ANGIOGRAPHIC PROCEDURE OR AN INTERVENTIONAL PROCEDURE USING AN 8FRENCH PROCEDURAL SHEATH FOR THE 8F ANGIO-SEAL STS DEVICE AND A 6F OR SMALLER PROCEDURAL SHEATH FOR THE 6F ANGIO-SEAL STS DEVICE.
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